01. Is consent from subjects required prior to prospective review of private medical information for the purpose of screening, recruiting, or determining eligibility of prospective subjects?
Under the pre-2018 Common Rule regulation (45 CFR 46), unless the research qualified for specific exemptions, prospective consent from the potential subject for recording of their identifiable private information being obtained for recruitment was required, unless waived by the IRB. For protocols subject to the revised (2018) Common Rule only, an IRB may approve certain screening or recruitment activities, or activities to determine eligibility, prior to obtaining informed consent. These include:
In this event, the PI does not need to request a waiver of consent, but these activities that will occur prior to obtaining informed consent must be clearly described in the IRB approved protocol. The solicited information should be limited to the minimum necessary for screening, or to determine study eligibility.
02. Is written consent of the subject always required for research that involves only web-based surveys or tasks with minimal-to-no interaction between the investigator and study subjects?
For minimal risk research being conducted remotely, the IRB may approve a web-based consent form or approve waiver of documentation of consent with no requirement for oral consent. When a research study is subject to the Privacy Act, (i.e., will collect identifiable private information about a subject), the prospective subject must be provided with written Privacy Act notification. If an investigator wishes to conduct an oral consent process and receive a waiver of documentation of consent, they must still at least offer to provide the Privacy Act notification in writing. A description of the plan should be included in the consent section of the protocol. When the subject will not be registered as a patient at Clinical Center, please refer to the section labeled Privacy Language for Studies Conducted Outside of the Clinical Center in the Consent Library. The Consent Library can be accessed on the OHSRP webpage titled Consent Templates and Guidance.
03. If the investigator is planning on obtaining consent remotely, or if they want to add this option to the consent process, how is this handled regarding the protocol? Alternatively, what if this process is anticipated to be needed only temporarily or for a few subjects?
If the protocol will include use of a remote consent procedure (e.g., by phone or videoconferencing), the process must be described in the protocol, and IRB approval must be obtained. Otherwise, if the plan to use the remote consent process is only temporary and for a few subjects (e.g., due to the pandemic), a single patient planned deviation request form may be submitted rather than a protocol amendment. If the investigator will be conducting such a process via telehealth, use only an approved synchronous video platform that meets required NIH security and privacy standards. For additional information, please refer to Policy 303 Intramural Program Telehealth Requirements which can be found here.
04. When obtaining consent from a study subject over the phone using a long form English consent, who needs to sign the consent and what dates are documented?
The subject should be provided with the consent form in advance of the consent conversation. After the consent process has been conducted and the investigator has responded to the subject’s questions, the subject signs the consent form noting the current date. The investigator documents the process in CRIS/medical record (or the research record if there is no medical record) in real time on the day of the consent conversation. When the signed/dated consent form is returned to the investigator who conducted the consent discussion, the investigator signs and dates the consent form with the date s/he received the signed the consent from the subject. The investigator should then record another note in CRIS/research record indicating the updated status and send a copy to medical records (or research record if there is no medical record) and provide a copy of the completed consent form to the subject. The date that the subject signs the consent form is considered their “date on study.” If, after the subject has signed the consent form, specimens and/or data are collected locally for research purposes, no analyses of these specimens and/or data may occur until the investigator has verified that the subject has returned a signed and dated informed consent document, unless the IRB has granted a waiver of documentation of consent.
05. What information about the consent process should be documented in the medical or research record?
NIH investigators should document the consent process in the subject’s record, and describe the method used for communication with the subject and the specific means by which the subject communicated agreement to participate in the study (e.g., their verbal response and signing of the informed consent document). Additional FAQs related to documentation of consent in CRIS are available at this internal link.
06. When is the “short form consent” process used?
The short form consent process is used when the subject is unable to read the long form version of the consent due to a language barrier. An interpreter is utilized for subjects who are unable to understand the language in which the long form consent is written.
07. Who can be an interpreter for the short-form consent process?
Whenever possible, a professional interpreter, who is in-person, should be used or, alternatively, a professional interpreter can be utilized via a telephone interpretation service. Use of a family member for interpretation is not permitted unless a professional medical interpreter cannot be located. The reasons for using a family member and the attempts made to locate a professional interpreter must be documented in the research record. Family members may not have adequate medical knowledge and are not trained as professional medical interpreters. Additionally, family members may not be impartial or may try to speak for the subject which can limit the subject’s decision-making process. (Also see Question 20 for more information about when an investigator may server as the interpreter.)
08. How is the consent process conducted when the subject speaks and understands English but is blind or illiterate?
When the subject speaks and understands English but is illiterate or blind, the English long form should be used to obtain consent from the subject. The short form consent document should not be used. The subject may use assistive technology (such as screen readers for sight-impaired individuals) to read the consent, or the consent form should be read to the subject. There must be a witness to the entire oral presentation of the consent. The witness then signs the witness line on the English long form consent. See the screenshot below. Subjects who are unable to sign their name can make their mark on the signature line. (e.g., They may make an “X,” or provide a fingerprint.) The consent notes in Clinical Records Information System (CRIS) or the research record should document the process and include a statement that there was a witness to the entire consent process and any special circumstances regarding documentation of consent.
09. How is the consent process conducted for non-English speaking subjects for whom no written language exists?
When conducting the consent process with a subject for whom no written language exists, the process is similar to that used with a blind or illiterate subject. There should be an oral presentation of the English long-form consent by the interpreter. There must be a witness (who can be the interpreter if they are willing to act as the witness) at the location of the investigator, who is present during the entire oral presentation. The subject must sign or make their mark on the consent, and the investigator and witness both sign the consent. The administrative block for interpreters must be completed, and there must be a note in CRIS or the research record documenting the consent process used in this circumstance.
10. How is the consent process conducted for non-English speaking subjects who are unable to read the short form in their own language because they are blind or illiterate?
Even though the subject is illiterate or blind, written documentation of consent is still required, unless waived by the IRB. This is a requirement of the regulations and in addition, it is respectful of the participant. They may want to share the consent form with family members or health care providers who can read the consent form written in the subject’s language. Alternatively, they may have access to assistive technology (e.g., screen reader) that can “read” the consent form to them in the language they understand. When conducting the consent process in this situation, there must be a witness who is present during the entire oral presentation. The witness can be the interpreter if they are willing to act as the witness. Interpreters scheduled by the CC Language Interpreter Program (LIP) must sign as the witness (See FAQ #12 below.)
The English long form consent is used as the basis for discussion, whether or not there is a translated long form. The investigator obtaining consent reads the consent in English and the interpreter orally interprets the English words of the investigator and will facilitate the question-and-answer phase of the informed consent process between the non-English speaking potential subject and the investigator. The interpreter’s role is to facilitate verbal discussions between parties that do not speak the same language. Having the subject know what is in the translated long form, even if they are illiterate or blind, is optimal because the required information about the study is contained in the consent form.
If there is a translated long form consent in the subject’s language, the subject, the investigator obtaining consent, and the witness sign the translated long form consent. Subjects who are unable to sign their name can make their mark on the signature line. (e.g., They may make an “X,” or provide a fingerprint. The administrative block for interpreters must be completed. The subject is provided with a copy of the signed translated long form that is in their language.
If there is no translated long form in the language of the subject, the English long form consent is used as the basis for discussion, and the short form process is used. In this case, the subject and witness sign the short form consent that is written in the subject’s language (or, if applicable, the subject makes their mark as noted above), and the investigator obtaining consent and the witness sign the English long form consent. The administrative block for interpreters must be completed. The subject is provided with copies of both the signed English long form and translated short form consents.
If there is no translated long form or short form in the language of the subject, the subject cannot be enrolled until the consent form (preferably the long form consent, but at the least, the short form consent document) is translated into the language of the subject and submitted to the IRB along with the certificate of translation and is approved by the IRB prior to use.
In all cases, the consent note in Clinical Records Information System (CRIS), or the research record should document the process and include a statement that there was a witness to the entire consent process and any special circumstances regarding documentation of consent.
While the above scenarios provide an acceptable path to document informed consent, OHSRP expects investigators to carefully consider whether it is appropriate to enroll an individual in the study in the situations described above. In particular, enrolling an illiterate non-English speaking person when the only document we can provide is the translated short form, which they cannot read without assistance, provides that person with no study specific information to use for future reference. The challenges with effective and meaningful communication to assure there is adequate understanding of the risks of the study and the requirements of study participation will continue to be present throughout the study. In such circumstances, investigators must be able to justify that the potential benefits outweigh the risks for that individual participant.
11. When a short form consent document in the language that can be read by the subject is used, and the written IRB-approved summary of what is to be said to the subject is the English long consent form, who signs the English long form and who signs the short form?
For the English long form consent: the investigator obtaining consent and the witness sign the English long form consent document. The interpreter may also act as the witness.
Alt Text: Image title is English long form consent. Image shows the signature page of the English long form consent. There is an arrow pointing to the Signature of Investigator line. The arrow text indicates that the Investigator obtaining consent needs to sign on this line. Image then shows the signature page of the English long form consent. There is an arrow pointing to the Signature of Witness line. The arrow text indicates that the Interpreter or separate witness to the entire consent process needs to sign on this line.
For the short form consent that is in the language that can be read by the subject: The subject and the witness sign the short form consent document.
Alt Text: Image title is Required signatures on the short form consent. Image shows the Spanish short form consent. There is an arrow pointing to the participant line. The arrow text indicates that the participant needs to sign on this line. Image then shows an arrow pointing to the Signature of Witness line. The arrow text indicates that the Interpreter or separate witness to the entire consent process needs to sign on this line.
Confirm that the witness has signed both the short form in the language of the subject and the English long form used as the summary of what is to be said to the subject.
Alt Text: Image title is Required signatures when using the short form process. Image shows the Spanish short form consent as an example. There is an arrow pointing to the participant line. The arrow text indicates that the participant needs to sign on this line. Image then shows an arrow pointing to the Signature of Witness line. The arrow text indicates that the Interpreter or separate witness to the entire consent process needs to sign on this line.
12. When a Clinical Center (CC) interpreter facilitates the informed consent process, is the interpreter required to also serve as the witness?
Yes. Interpreters in the CC scheduled by the CC Language Interpreter Program (LIP) are either NIH staff members who are federal employees or contract employees whose job is to provide medical interpretation. Interpreters scheduled by the CC LIP must sign the short and long form consent as the witness when facilitating the short form consent process, because they speak both languages. In all cases, the identity of the interpreter will be noted as indicated in Questions 14 and 17 below. The witness must be present for the entire oral presentation.
Before starting the consent process, confirm with the interpreter if they are willing to witness the consent. If the interpreter declines to act as the witness, please contact the CC LIP immediately at 301-496-2792 and they will assist.
13. What happens if the short form consent process is conducted in person, but the interpreter is on the phone?
A telephone service interpreter cannot act as a witness since they are not physically present to observe the consent process. Another individual, fluent in the language of the subject and in English, must observe the entire consent process at the site of the investigator and sign as the witness. Information regarding the interpreter should be included in the administrative sections of the long form and short form consent documents as described in Question 14.
In the vary rare instance that a witness who is fluent in both English and the language of the subject cannot be located, then the witness should verify with the interpreter that the subject understands the information presented, that all questions have been satisfactorily addressed, and that the subject agrees to participate. The witness, or investigator, obtaining informed consent should document this as a note in the record documenting the short form consent procedure.
14. How do you document the use of an interpreter on the long and short form consents?
Both the English long form and the translated short form includes a section titled NIH ADMINISTRATIVE SECTION TO BE COMPLETED REGARDING THE USE OF AN INTERPRETER which must to be completed when the short form consent process is used. (Note: On the translated short form, this section will be in the subjects preferred language.) This section allows NIH staff to attest that an individual speaking both English and the subject’s preferred language facilitated the consent process and also indicates whether the individual acting as the interpreter also served as the witness to the short form consent process.
If the individual providing interpretation services did not serve as a witness, the interpreter’s name (for on-site interpreters), or ID number (for telephone-based interpreters), should be entered in the designated 2 nd field below.
English long form administrative block
Examples of scenarios
15. What is required when the short form consent process is used to obtain consent by phone from a subject who is not in the same location as the investigator? This includes consent processes using an interpreter who is either on the phone (remote from the investigator) or who is present with the investigator.
The difference from the earlier examples relates to the location of the individual who will serve as the witness, and timing of the investigator and witness signatures.
16. What process is used if obtaining consent using the short form consent and the consent process is being conducted remotely with the witness not in the same location as the investigator (e.g., because the witness is teleworking due to COVID and is also on the phone or is witnessing via a telehealth platform)?
The short form consent process requires that the witness attest, by signature, to the validity of the consent process and the subject’s agreement to participate. If the witness is unable to sign the required documents, it is not acceptable for the PI to make a notation in the research record on behalf of the witness.
In such scenarios, the acceptable options for obtaining informed consent are to either: 1) translate the full consent into the language of the subject, or 2) if it is urgent to enroll the subject, the short and long form consents could be provided electronically to the witness, who will then sign and return the documents electronically. Note, that such signatures must be “wet” signatures using a pen, mouse or stylus and not electronic signatures.
If these options are not feasible, then it may not be possible to enroll the subject.
17. What documentation should be entered in the Clinical Records Information System (CRIS) when an interpreter is used for the short form consent process?
The CRIS documentation of the Informed Consent Progress Note has been updated to include the required fields related to use of interpreters and witnessing the consent process. Whenever an interpreter facilitates the informed consent process, the PI or investigator who is obtaining consent should complete the check box fields in the progress note and include the name or ID number of the interpreter in the designated field.
18. Who signs the IRB-approved fully translated (non-English) long form consent document?
If investigators anticipate enrolling subjects who speak a specific language other than English, the English long form consent should be fully translated into that language and submitted to the IRB for approval. In this case, an interpreter is also used to facilitate the discussion and answer the subject’s questions, and the investigator obtaining consent and the subject both sign the fully translated long form consent (as they would if the long form was in English).
In this case, since an interpreter is used but a witness is not required on the long form consent, the second box in the administrative section should be checked to indicate that the interpreter facilitated the consent process but did not serve as the witness.
19. When an interpreter is used during the consent process using a translated long form, how is this documented in the consent note in CRIS?
Check “yes” to the question, “Interpreter used during the consent process?” Fill in the name or ID code of the person providing interpretive support. Under additional notes, include a statement that a translated consent long form was used. See below.
20. Can a bilingual investigator approved by the IRB to obtain consent do so using the translated long consent form or the short form process?
If the investigator is truly fluent in English and the language of the subject, consent may be obtained using the IRB approved translated long form if it exists, and no witness is needed. When the short form process is used because the long form has not been translated into the subject’s language, the bilingual investigator conducts the consent process in the language of the subject and explains all applicable elements of consent using the English long form as the summary of what is said to the subject. The investigator obtaining consent cannot act as the witness, so the second option in the administrative block noted in FAQ question 9 above is checked, and the investigator’s name is noted on the provided line. In such cases, there must be a separate individual present to observe the entire consent process who signs as the witness.
21. What happens when there is no short form in the language of the proposed subject?
If the long form has not been translated into the language of the proposed subject, the subject should not be enrolled until a short form in their language is available. If you need a short form that is in a language which is not available on the IRB website, then you must obtain a translation of the appropriate English short form version. A resource for obtaining a translation is the NIH Library. Once you receive the translation, submit the translated short form and the certificate of accuracy to the IRB via PROTECT using a modification form.
22. How are embedded questions on the English long form consent handled when the short form consent process used?
The interpreter should ask the subject the embedded question and convey their response to the investigator obtaining consent. The investigator indicates the subject’s response on the long form ICF. Neither the interpreter nor the subject should record the response. This process should also be described in the consent note in CRIS or the research record.
23. How should assent of a potential minor subject who does not read/speak English be conducted when the IRB has only approved use of an English assent form for minor subjects of a specific age?
Verbal assent should be obtained from the minor, and the process should be documented in the consent note. NIH does not have translated short form assent documents.
When obtaining assent from a non-English speaking older minor, if there is a translated long form and the IRB has approved a process that allows older minors to provide their assent on the long form, then the older minor may read and indicate their assent on the translated long form. Otherwise, verbal assent should be obtained and documented as above.
24. What is the process for obtaining reconsent from a non-English speaking subject who previously signed a translated long form when the IRB approves a consent modification and requires that subjects provide reconsent using the updated approved ICF?
Submit the updated long form English consent document for translation. (A resource for obtaining a translation is the NIH Library.) Upon receipt, submit the newly translated long form, along with the certificate of translation, to the IRB for approval. If the IRB requires reconsent prior to translation and IRB approval of the updated consent in the subject’s language (for example an important new risk needs to be communicated before the IRB approved English consent form can be translated and approved by the IRB), then using a qualified medical interpreter, the study team should verbally inform the participant of the changes and document this in the research and/or medical record. Once the translated consent is available, those participants should be formally reconsented with the revised translated consent document. The participant’s signature and that of the person obtaining consent should be entered on the revised translated consent document. This process should also be documented in the subject’s medical or research record.
25. Changes to NIH HRPP Policy 301, Informed Consent (effective March 1, 2024) provided updated requirements for translation of long form consents into the language of the non-English speaking potential participant. These changes were further described in Guideline for Enrolling Non-English Speaking Subjects. Do these policy changes apply to research deemed to be exempt research by the NIH IRB?
Exempt research is not subject to the Common Rule requirements for consent nor is there an equivalent short form process for exempt research. However, the NIH policy requires that there be a consent information sheet provided for most exempt research (see https://policymanual.nih.gov/3014-301#E.1).
Given that much of this type of research is survey research, and/or participants are performing a task online, the scientific validity of the data would likely require that the research be in a language that can be read by the participant. In addition, if the expectation is that the person has read the consent paragraph at the front end of the survey or task, and that by proceeding they are agreeing, then it would have to be provided to the person in a language they can understand to be meaningful and valid.
While our policy does not specifically address exempt research, we would expect investigators to use good judgement and best practices to determine when translation is needed, for both ethical and scientific validity reasons.
26. May Visiting Fellows (VFs), Intramural Research Training Awardees (IRTAs), and Cancer Research Training Awardees (CRTAs) serving as Associate Investigators participate in the informed consent process and sign the informed consent document?
Except as described below, VFs, IRTAs, and CRTAs serving as Associate Investigators may observe or participate in the informed consent process only if they are under the direct and constant supervision by a qualified NIH federal employee investigator. These trainees may not sign the informed consent document.
Post-doctoral IRTAs/CRTAs and post-doctoral VFs who are Associate Investigators may obtain the informed consent of a prospective subject without the presence of a qualified NIH federal employee investigator only if they have completed the expanded training requirements listed in MC 3014-301 Informed Consent that include the following:
27. Do Clinical Fellows have to complete expanded training requirements listed in MC 3014-301 Informed Consent in order to obtain consent?
The policy permitting post-doctoral IRTAs/CRTAs and Visiting Fellows (VFs) to obtain informed consent so long as they meet expanded training and policy requirements is specific to these trainees. IC staff should NOT confuse IRTAs/CRTAs and VFs with Clinical Fellows and Research Fellows who are federal employee investigators who can independently obtain informed consent. For more information, you can look up various types of fellows including helpful information about fellow hiring authorities here: https://oir.nih.gov/sourcebook/personnel/ipds-appointment-mechanisms/official-list-approved-intramural-professional-designations-ipds
28. When is the signature of both parents required on the informed consent document to enroll a minor on a research study?
If the IRB has determined that signature of both parents is required, permission must be obtained from both parents unless one is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. However, for research taking place at an NIH site when the IRB has approved the study as needing permission from only one parent, in cases where parents share joint legal custody for medical decision-making of a child (e.g., by a custody agreement or court order), both parents must give their permission regardless of the risk level of the research. Exceptions may include if one parent has since died, become incompetent, or is not reasonably available. However, in such cases, if one of the parents wants to give the decision-making responsibility to the other parent, they can do so. In this situation, the parent who wants to give up such responsibility must write and sign a letter to the study PI stating they want the other parent to make decisions about the child as they relate to their study participation at NIH. It can indicate the parent’s willingness to give up this responsibility for a specific duration of time, or they can indicate that they are doing so indefinitely or until they decide otherwise. This letter does not need to be notarized.
29. When the IRB requires two parents to provide written parental permission for enrollment of their child on a research protocol, how are the embedded questions in the consent form handled since there is only one line for a parent’s initials?
Even if both parents are required to sign the consent form, only one parent needs to initial the embedded questions. This is true whether documentation of consent is collected on a paper form or on an electronic consent form, e.g., using iMed. Please note however that both parents must agree on the responses to the embedded questions to allow the research to move forward.
30. If the IRB requires written documentation of consent prior to research participation, what is the process for obtaining consent from a potential subject who is unable to sign the consent form due to disability (e.g., being paralyzed)?
If the potential subject is able to speak, verbal consent may be obtained. If the individual is unable to speak, they can be entered into a study if they are competent and able to indicate approval by other means. However, if the protocol states that written documentation of consent is required, the alternative procedure that will be used to indicate the subject’s consent (including verbal consent) must be prospectively reviewed and approved by the IRB. This should be done by submitting a Single Patient Modification Request in the electronic IRB system.
When a method of obtaining consent other than written documentation is utilized (for example, verbal consent for a subject who does not have the ability to provide written consent), investigators must document the method used for communication with the subject and the specific means by which the subject communicated agreement to participate in the study in the documentation of consent note in the subject’s medical or research record. When feasible, it is advisable to have a witness present.
1. What is meant by new risks that are discovered while research is ongoing?
When a protocol undergoes initial approval, the protocol’s consent document is reviewed to ensure that all known risks to research subjects are included and communicated in a way that can be easily understood. These risks can vary depending on the type of research study that is being conducted.
Once a study starts enrollment, there may be new risks that are identified that were not anticipated. These can be risks to the physical or mental safety of participants, risks to the rights or privacy of subjects, or even unanticipated issues with confidentially. It is not unexpected for this to happen and these new risks need be communicated so that subjects can make an informed decision if they would like to continue to participate in the research.
2. What are some ways that new risks are identified during ongoing research?
There are several ways that new risks can be identified. The most common way is from events that occur on a research protocol. These could be physical or mental adverse events which were not included in the consent document or that occurred at a greater severity or frequency than previously known. Another example would be a large data breach that affected all your research subjects. This should sound familiar because these are examples of unanticipated problems that are reportable to the IRB. If you are reporting a possible unanticipated problem to the IRB, you should be considering if there is a new risk that needs to be communicated to subjects.
New risks to your research participants may also be identified outside of your protocol. The most common ways are through new research publications, drug safety-related labeling changes, and sponsor’s or manufacturer’s IND Safety reports.
3. What is the appropriate way to inform research participants of new risks that are discovered during the research?
Informing research participants of new risks is part of the ongoing consent process that occurs from first contact and continues until the participant is taken off study. Just like your initial consent document needs to contain IRB approved language, the language used to communicate new risks also must receive prior IRB approval. There are several ways that new risks can be communicated to participants. The mode of communication can vary based of the type of information being communicated and where the participants are in the research process. Your plan for notification of subjects should be a part of your proposed actions at the time you notify the IRB of the new risks in the eIRB system.
4. What if there is an immediate risk to the safety of the participants that needs to be communicated?
If there is a safety risk to participants that requires action to eliminate apparent immediate hazards, the investigator may inform the participants using language not approved by the IRB. However, new information that puts research participants at this level of immediate risk would also most likely be reportable via a Reportable New Information (RNI) form. You may be required to follow-up this initial discussion with IRB approved language using a method discussed in question 3. If there are any questions that occur during an emergency situation, the investigator is encouraged to contact the IRB or OHSRP Leadership directly.
5. How do I document that I have appropriately informed participants of any new risks that could affect their willingness to continue their participation?
It is not sufficient to only inform the subjects of any new risks. It is also the responsibility of the investigator to timely and adequately document the process. If you have access to a medical record system where you document research activities, such as CRIS at the NIH Clinical Center, then any discussion regarding communication of risk should be documented in a note. This is important since this is proof that the investigator has upheld their responsibilities for auditing purposes. If no medical record is available, then the contacts should be documented in the research record.